Usage of EMBRACE TM in Gujarat, India: Survey of Paediatricians

Research ArticleUsage of EMBRACETM in Gujarat, India:Survey of Paediatricians

Somashekhar Nimbalkar,1,2 Harshil Patel,1 Ashish Dongara,1

Dipen V. Patel,1 and Satvik Bansal1

1 Department of Paediatrics, Pramukhswami Medical College, Anand, Karamsad, Gujarat 388325, India2 Central Research Services, Charutar Arogya Mandal, Anand, Karamsad, Gujarat 388325, India

Correspondence should be addressed to Somashekhar Nimbalkar; somu [email protected]

Received 26 June 2014; Revised 26 September 2014; Accepted 10 October 2014; Published 30 October 2014

Academic Editor: Masaru Shimada

Copyright © 2014 Somashekhar Nimbalkar et al.This is an open access article distributed under theCreativeCommonsAttributionLicense, which permits unrestricted use, distribution, and reproduction in anymedium, provided the originalwork is properly cited.

Aim. EMBRACETM is an innovative, low cost infant warmer for use in neonates. It contains phase change material, which stays atconstant temperature for 6 hours. We surveyed paediatricians using EMBRACETM regarding benefits, risks, and setup in which itwas used in Gujarat.Methods. Questionnaire was administered telephonically to 52 out of 53 paediatricians. Results. EMBRACETM

was used for an average of 8.27 (range of 3–18, SD = 3.84) months by paediatricians. All used it for thermoregulation duringtransfers, for average (SD) duration of 42 (0.64)m per transfer, 62.7% used it at mother’s side for average (SD) 11.06 (7.89) h perday, and 3.9% prescribed it at home. It was used in low birth weight neonates only by 56.9% while 43.1% used it for all neonates.While hyperthermia was not reported, 5.9% felt that EMBRACETM did not prevent hypothermia. About 54.9% felt that they couldnot monitor the newborn during EMBRACETM use. Of paediatricians who practiced kangaroo mother care (KMC), 7.7% havelimited/stopped/decreased the practice of KMC and substituted it with EMBRACETM. Conclusions. EMBRACETM was acceptableto most but concerns related to monitoring neonates and disinfection remained. Most paediatricians felt that it did not hamperKMC practice.

1. Introduction

Lack of thermal protection is one of the major challengesfaced by developing nations for newborn survival [1]. InIndia, the prevalence of hypothermia varies widely but recentestimates in normal newborns in community settings arearound 31% and about 32% in hospital settings, but theseincluded mostly normal weight newborns [2, 3]. The preva-lence can be estimated to be even higher for low birth weightnewborns. A greater proportion of child deaths in thewesternand southern parts of India are attributable to low birthweight and premature babies [4]. Almost 2.8million neonataldeaths occurred in the year 2013 globally, of which 73%deathsoccurred during the first seven days of life [5]. Neonatalmortality contributes to more than half of the under-fivemortality in countries such as India [5].The rates of decline inthe last decade have been the slowest for neonatal mortality

[6]. Every 1∘C below 36∘C on admission increased the odds oflate onset sepsis by 11% and of death by 28% [7].

Hypothermia in newborns is rarely a direct cause of deathbut rather exists as a comorbid condition along with birthasphyxia, neonatal infections, and preterm birth and leads toa substantial amount of mortality. The hypothalamus alongwith various endocrine organs is responsible for the processof thermoregulation in newborns. In LBW and pretermbabies, these mechanisms are overwhelmed resulting inmetabolic disturbances which ultimately result in neonataldeath, either directly by hypothermia or indirectly [1]. Inpreterm infants there can be a rapid drop in temperature byalmost 0.5∘C to 1∘C per minute. Cold ambient temperature,intrahospital transfers, low temperature of hospital beds andpoor warm chain practices during resuscitation, and lateonset of breastfeeding, and so forth, are some additionalfactors which hasten the onset of hypothermia [8]. In a recent

Hindawi Publishing CorporationAdvances in Preventive MedicineVolume 2014, Article ID 415301, 5 pageshttp://dx.doi.org/10.1155/2014/415301

2 Advances in Preventive Medicine

study of 300 consecutive neonates, almost 47% neonateshad hypothermia in spite of about 75% being institutionaldeliveries [9]. In developing countries neonatal hypothermiaoften goes unnoticed and unaddressed [10].

Various measures to prevent hypothermia are practicedby healthcare providers and these vary with the population ofneonates being catered to. Maintaining a delivery room tem-perature ofmore than 25∘C, wrapping the baby in clean linen,drying, using baby hat, starting skin-to-skin contact withmother after delivery also termed as kangaroo mother care,placing the neonate under radiant warmer, delaying bathing,usage of chemical mattresses, and wrapping the neonate inplastic are all practiced by healthcare providers [11]. Kangaroomother care has shown to prevent hypothermia along withother benefits to the child which include increased breastfeeding and better weight gain [12]. An estimated 4,50,000babies can be saved worldwide every year if supportive carein the form of kangaroo mother care is provided by health-care providers [13]. The most recent systematic review onkangaroo mother care in low birth weight infants has showna reduction in the risk of mortality (risk ratio of 0.60, 95%confidence interval (CI) 0.39 to 0.92) as well as reduction inthe risk of hypothermia (risk ratio of 0.34, 95%CI 0.17 to 0.67)and reduction of nosocomial infection/sepsis (risk ratio of0.45, 95% CI 0.27 to 0.76) when evaluated at discharge or 40-41 weeks postmenstrual age. Even at the latest follow-up theKMC was associated with reduction of mortality and sepsis[14]. In areas where there are fewer healthcare providersand even lesser resources a simple technique to prevent andmanage hypothermia is required. The EMBRACETM warmeris a small sleeping bag-like apparatus which has in its back areusable pouch of phase change material that can be heatedto 37∘C and can maintain that temperature for several hours.It is cheap, reusable, portable, and hygienic and does notrequire constant electricity [15]. This has been developed bystudents at Stanford University and has been marketed inIndia for the last two years. There have been no publishedtrials of EMBRACETM though there are four studies whichare listed on clinical trial registries [16–19].We surveyed usersof EMBRACETM inGujarat for their assessment of its benefitsand the various settings in which it was being used.

2. Materials and Methods

The survey questionnaire was developed and was consensu-ally validated by four neonatologists at the neonatal intensivecare unit (NICU) of Shree Krishna Hospital, Karamsad(Appendix). Over a span of 2 months, the questionnaire wasadministered by telephone to 52 out of a population of 53practitioners who were using EMBRACETM at their setups indifferent cities across the state of Gujarat. One paediatriciandeclined to answer the survey. The study was approved bythe institutional ethics committee.

Instrument. The questionnaire comprised of 22 questionsregarding the use of EMBRACETM, for instance, what werethe indications for using EMBRACETM, the average durationof the use of the product per day, major advantages and

disadvantages as experienced by the paediatricians whileusing EMBRACETM, and the impact of EMBRACETM on thepractice of kangaroo mother care. Demographic informationof the hospitals at which the participating paediatricianspracticed was also taken into account.

3. Results

The paediatricians have been using EMBRACETM since amean time of 8.27 months (range = 3–18 months, SD = 3.84).The product is mainly used for thermoregulation duringtransfers (100%) and during hospital stay when the baby is atthe mother’s side (62.7%) and is even prescribed at home ina small proportion of cases (3.9%). When used for transfers,EMBRACETM was utilized for a mean (SD) duration of 42(0.644) minutes per transfer, and when used to keep the babywarm while at the mother’s side, it was used for a meanduration of 11.06 h (SD = 7.98) a day.

We attempted to determine the target population forEMBRACETM use. We found that 56.9% of paediatriciansused it for low birth weight neonates and 43.1% paediatriciansused it for normal weight and low birth weight neonates.None of the paediatricians used the product after deliveryunless the neonate was vitally stable. Of all the paediatricians,54.9% used EMBRACETM within 12 h of delivery, 31.4% usedit within 12–48 h after delivery, and 13.7% used it after 48 h ofdelivery.

We determined that 98% of the paediatricians were com-fortable using the product routinely and 100% of the paedia-tricians felt that the babies were comfortable while placed inEMBRACETM. All of the paediatricians (100%) found EMB-RACETM to be a useful product for transfers, both intra- andinterhospital.More than half of the paediatricians (58.8%) didnot report any disadvantage or problems while using EMB-RACETM, while the rest encountered one problem or theother. Of the paediatricians, 14.3% felt that EMBRACETM

was too costly and not worth its price, 33.3% reported issuesrelated to heating and temperature regulation related issues,33.3% paediatricians had issues related to cleaning, disinfec-tion, size issues (too large for ELBW infants), charging, andmonitoring, and 19% paediatricians found a combination ofthe above-mentioned issues.

Of the paediatricians using EMBRACETM for babies keptat the mother’s side, 94.1% did not notice any weight gainin infants and 62.7% found it to prevent hypothermia whenthe baby was at the mother’s side. But, 5.9% paediatriciansdid not find EMBRACETM to be a useful product to preventhypothermia in newborns. No doctor reported hyperthermiaas a consequence of EMBRACETM use.

Out of all the paediatricians using EMBRACETM, 54.9%felt that they could not monitor the newborn effectivelywhen placed within EMBRACETM. Of those who felt thatthey could monitor the infant, 95.7% monitored only pulseoximetry, whereas 4.3% said that they monitored both thechest rise of the baby and pulse oximetry readings.

All the participating paediatricians (100%) had heardabout kangaroomother care, out of which 98%were formally

Advances in Preventive Medicine 3

trained in kangaroo mother care (KMC), and 74.5% paedia-tricians practiced KMC at their setup. Of the paediatricianswho practiced KMC, 7.7% have limited/stopped/decreasedthe practice of KMC and substituted it with EMBRACETM forthermoregulation. All 7.7% of these doctors were involved inprivate sector. On further questioning, healthcare providersgave various reasons for reducing KMC. These included“more compliance of EMBRACETM with nurses and rela-tives,” “counselling for KMC requires 30 minutes,” “trainingstaff is a headache,” “hygiene issues in mother,” “EMBRA-CETM is equivalent to KMC,” “KMC is not possible in privatesetups,” and “there is no space to give KMC.” 90.4% paediatri-cians included in the study were from private sector whereasonly 9.6% were from public sector. Among the doctors whowere involved in private practice, 27.6%did not practice KMCat all whereas all the doctors in public sector practiced KMCat their setups. EMBRACETM was being used for babies keptby mother’s side by 38.2% private practitioners, whereas only1 out of the 5 practitioners in public sector used the productfor this purpose. Ninety-two percent paediatricians levied nocharges on the patients for using this product, whereas 8%paediatricians levied nominal charges for maintenance of theproduct. No doctor charged more than 500 rupees per day.

4. Discussion

The current survey reports on the usage of EMBRACETM

of almost all healthcare providers having EMBRACETM inGujarat in mid-2013. In a recent survey on neonatal resus-citation carried out in Gujarat there were a similar number ofparticipants that participated and hence we believe that thissurvey on EMBRACETM is representative of current neonatalpractice in Gujarat [20].

Although published literature on the benefits of EMBRA-CETM is not available the fact that it has a relatively large num-ber of users within a short period of time is an indicator of theneed for a low-cost product to prevent neonatal hypothermia.It can be argued that KMC is a better and proven interventionthanEMBRACETM formanagement of hypothermia.Howev-er providing KMC encompasses support from the family andthe healthcare providers. Though the current study has notaddressed this aspect, the authors surmise that this supportis not available due to rapid uptake of EMBRACETM and asizeable number of providers stopping KMC. Additionallythough a neonate can be transferred while in KMC positionwith mother/relative, it is often not feasible because ofunavailability of mother/relative to provide KMC duringtransfers or in case of urgent intra- or interhospital transfersof neonates when there is not enough time to prepare themother/relative for providing KMC, and so the use of a low-cost product like EMBRACETM to prevent neonatal hypo-thermia is warranted.

The results indicate that these healthcare workers arecomfortable with using EMBRACETM suggesting that thedesign of the product is simplistic in nature and does notrequire extensive training. Incubators and radiant warmersare complex devices which are costly and require trainingand their usage practices vary with different neonatal units,

experience, and knowledge [21]. Availability of EMBRACETM

allows healthcare providers to use it in situations whereintheywould have utilized a radiant warmerwith all of its atten-dant technical requirements, especially when KMC wouldbe nonfeasible to implement as already mentioned. UsingEMBRACETM as a sleeping bag kind of mattress allows thepaediatricians to reduce the complexity of care. Usage ofEMBRACETM for transport had universal appeal as com-pared to kangaroo mother care which requires training andextensive support before it can be effectively used. Howeverthe short duration of transport does not shed any informationof value, as increased neonatal mortality occurs when thetransport duration exceeds 1 h [9].

Healthcare providers shared their concerns about clean-ing, disinfection, and temperature regulation of the neonates.This is surprising as the training of EMBRACETM and the lit-erature pack provided describes these in detail. The concernsrelated to the EMBRACETM warmer being large for ELBWbabies are notable. EMBRACETM is provided with a cushionfor smaller neonates. However there was no specific problemrelated to usage in ELBW babies. Almost 40% healthcareproviders expressed their apprehension about the effective-ness of the product in preventing hypothermia although theywere all comfortable using it. Whether it is a design issue or atraining issue cannot be commented upon, due to the designof our survey. More detailed understanding of these conceptsis needed. There was not a single report of hyperthermiawhich possibly indicates the safety of EMBRACETM thoughour study design was not designed to study safety features.This is significant as EMBRACETM is being utilized in com-munity settings across theworldwithminimal supervision byhealthcare personnel. In a recent study of a thermal regulationbundle there was 2% incidence of temperatures >38∘C in avery low birth weight (VLBW) population [22]. Inability tomonitor the baby was another lacuna that EMBRACETM hasin a hospital setting. EMBRACETM has an internal monitorfor temperature of the phase change material but baby’stemperature cannot be monitored. The healthcare providersalso monitored oxygen saturation in these babies.

Kangaroo mother care is being proposed as a better alter-native to conventional carewithwide ranging benefits includ-ing reduction of neonatal mortality, hypothermia, and lengthof hospital stay [23].There aremanymore benefits that accruefrom KMC such as reducing maternal postpartum depres-sion, neonatal pain reduction, prolonged breastfeeding, andpositive infant development and parent child bonding. Thishas led to the concept that premies are exterogestationalfoetuses that require provision of continuous skin-to-skincontact to promote maturation [24]. It is well acknowledgedthat only a fraction of the neonates requiring KMC arereceiving it. It probably stems from viewing KMC as anoption available to poor people in low income countries,from absence of knowledge or from lack of engagement ofparents [24]. Measures to accelerate KMC need to be put inplace [25]. It is in this context that the finding that almost75% of the surveyed healthcare providers were using KMCwas gratifying. However, almost 8% had reduced/stopped thepractice of KMC after beginning to use EMBRACETM.While

4 Advances in Preventive Medicine

EMBRACETM does prevent hypothermia it does not have theadditional advantages that KMC has.The authors believe thatthis finding has serious implications for neonatal health inthe long term. Efforts to promote KMCwill possibly face stiffresistance from healthcare providers using EMBRACETM asit is a therapy which is easy to administer and even easier tomonitor. KMC on the other hand requires training of staff,counselling of parents who are often unwilling and if givenan alternative may choose EMBRACETM, monitoring, andlarger space utilization in the hospital. The benefits of KMCaremore in the long term and are not really seen or felt by thehealthcare provider. With the introduction of technology inthe form of ultrasound machines in the 1980s there has beena reduction of the sex ratio in India to alarming levels [26].There has been no head-to-head trial of EMBRACETM versusKMC. It may be unethical to conduct one in most settingsas equipoise is no longer present. Yet the authors believe thata trial which compares these modalities of neonatal thermalmanagement is necessary, albeit in a design which is ethical.EMBRACETM may yet be utilized as an adjunct to KMCin situations where provision of KMC may be challenging.Studies focusing on the situations where these challengescan be faced and complimented by EMBRACETM need to beundertaken.

5. Conclusions

EMBRACETM is being used not only for transport but also forstabilization of the neonate in the neonatal intensive care unit.Paediatricians are using it in both LBW and normal weightnewborns and some have concerns related to disinfectionand monitoring of neonates. However, most paediatriciansfelt that it did not hamper the practice of kangaroo mothercare. As EMBRACETM usage increases, researchers workingin this area need to focus on developing strategies to improvethe uptake of kangaroo care while providing evidence basedguidelines for the usage of EMBRACETM. Efforts need to bemade to publish studies related to efficacy and effectivenessof EMBRACETM in clinical care of neonates.

Appendix

(1) Name.(2) Since when has EMBRACETM been used? (in

months).(3) In what kind of babies did you use EMBRACETM?

Normal birth weight, low birth weight, or both.(4) What was the purpose of use? Purpose of use—

transfers, prevent or treat hypothermia when baby isout of NICU or is with mother, both.

(5) Were there any charges levied if any? (in rupees).(6) Within how much time did the use of EMBRACETM

start after delivery? Immediately, after initial stabiliza-tion (within 6 hours), within 6–48 hours, or after 48hours.

(7) What was the duration of use of EMBRACETM perday in newborns for transfers? (in hours).

(8) What was the duration of use of EMBRACETM perday in newborns for purposes other than transfers?(in hours).

(9) Did you notice any pattern of weight gain in babiesafter the use of EMBRACETM? Yes, No.

(10) Are you comfortable in using EMBRACETM or not?Yes, No.

(11) What are themajor benefits of EMBRACETM noticed?No benefits, transfers, maintaining warm tempera-tures while at mother’s side, or combination of any.

(12) Have any newborns developed hypothermia whileplaced in EMBRACETM? Yes, No.

(13) Have any newborns developed hyperthermia whileplaced in EMBRACETM? Yes, No.

(14) Are newborns comfortable while placed in EMBRA-CETM? Yes, No.

(15) Do you use EMBRACETM for transfers? Yes, No.(16) Are you able to monitor newborns kept in EMBRA-

CETM? Yes, No.If yes, what parameters can you monitor? Respiration(chest rise), pulse oximetry, or both.

(17) Is there any disadvantage of using EMBRACETM? Yes,No.If yes, costly product, heating and temperature reg-ulation related issues, other technical issues like sizetoo big for ELBW babies, charging, cleaning, andmonitoring issues, or combination of any.

(18) Have you heard of kangaroo mother care? Yes, No.(19) Have you been trained in kangaroo mother care

formally or otherwise? Yes, No.(20) Have you ever used kangaroo mother care at your

setup before today? Yes, No.(21) Did you stop/limit/decrease using KMC after buying

and using EMBRACETM? Yes, No, or not applicable asnever used KMC.

(22) What is the number of hours that you subject the babyto KMC? (in hours).

(23) Address of the hospital.

Conflict of Interests

None of the authors have any conflict of interests to disclose.

Acknowledgments

Thanks are due to Central Research Services, Karamsad, forproviding statistical support and review of the paper andAmee Amin for editing the paper. This work was supportedby all the authors themselves.

Advances in Preventive Medicine 5

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Usage of EMBRACE TM in Gujarat, India: Survey of Paediatricians